(19 days)
No
The description focuses on traditional chemistry analysis using slides and instrumentation, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic (IVD) product designed to quantitatively measure C-reactive protein (CRP) concentration. It is used for diagnostic purposes and does not directly treat or alleviate a disease or condition.
Yes
The device quantitatively measures C-reactive protein (CRP) concentration in serum and plasma, which assists in medical diagnosis.
No
The device description explicitly states it is comprised of "Vitros Chemistry Products" (slides and calibrator kit) and the "Vitros Chemistry System - instrumentation," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Function: The device is designed to "quantitatively measure C-reactive protein (CRP) concentration in serum and plasma." This is a diagnostic test performed on biological samples outside of the body.
- Components: The description details the use of "Vitros Chemistry Products CRP Slides" and "Vitros Chemistry Products Calibrator Kit 7," which are reagents and calibrators specifically used for in vitro diagnostic testing.
- System: The device is part of the "Vitros Chemistry System," which is an automated system for performing chemistry tests on body fluid specimens.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vitros Chemistry Products CRP Slides
For in vitro diagnostic use only.
Vitros Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma.
Vitros Chemistry Products Calibrator Kit 7
For in vitro diagnostic use only.
Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros Chemistry Systems for the quantitative measurement of CRP.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JIT
Device Description
The Vitros Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multilayered analytical element of a Vitros slide.
The system is comprised of two main elements:
-
The range of Vitros Chemistry Products (in this case Vitros Chemistry Products CRP Slides and Vitros Chemistry Products Calibrator Kit 7), which are combined on the Vitros Chemistry System to perform the Vitros CRP assay.
-
The Vitros Chemistry System - instrumentation, which provides automated use of the chemistry slides. Vitros 250 and 950 Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K922072 and K946090, respectively).
The Vitros Chemistry System and Calibrators are dedicated specifically for use only with the Vitros Chemistry Products range of products.
The Vitros System uses common reagents. The Vitros Chemistry Products Specialty Diluent and Vitros ImmunoWash fluid were cleared by previous 510(k) pre-market notification (K962235 and K942610, respectively).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured CRP values spanning the reportable range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K922072, K946090, K962235, K942610
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
Summary Information
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 103062
-
Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive Name, Rochester, New York 14626-5101 Address, (585) 453-4253 Contact
Contact Person: Darlene J. Phillips -
Date Special 510(k) prepared: 25 February2003 2. Preparation Date
-
Trade or Proprietary Name: 3. Device Vitros Chemistry Products CRP Slides name Common Name: CRP test Classification Name: C-reactive protein immunological test system (21 CFR 866.5270)
-
The Vitros Chemistry Products CRP Slides (modified) and Vitros 4. Predicate Chemistry Products Calibrator Kit 7 are substantially equivalent to the Vitros Chemistry Products CRP Slides (current slide) and Vitros Chemistry Products Calibrator Kit 7.
Continued on next page
Ortho-Clinical Diagnostics, Inc.
1
510(k) Summary, Continued
| 5. Device
description | The Vitros Chemistry System uses Vitros Slides to perform discrete
chemistry tests on body fluid specimens. All reactions necessary for a
single quantitative measurement take place within the multilayered
analytical element of a Vitros slide.
The system is comprised of two main elements:
-
The range of Vitros Chemistry Products (in this case Vitros Chemistry
Products CRP Slides and Vitros Chemistry Products Calibrator Kit 7),
which are combined on the Vitros Chemistry System to perform the
Vitros CRP assay. -
The Vitros Chemistry System - instrumentation, which provides
automated use of the chemistry slides. Vitros 250 and 950 Chemistry
Systems were cleared for market by separate 510(k) pre-market
notifications (K922072 and K946090, respectively).
The Vitros Chemistry System and Calibrators are dedicated specifically
for use only with the Vitros Chemistry Products range of products.
The Vitros System uses common reagents. The Vitros Chemistry Products
Specialty Diluent and Vitros ImmunoWash fluid were cleared by previous
510(k) pre-market notification (K962235 and K942610, respectively). |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. Device
intended use | Vitros Chemistry Products CRP Slides
For in vitro diagnostic use only.
Vitros Chemistry Products CRP Slides quantitatively measure C-reactive
protein (CRP) concentration in serum and plasma.
Vitros Chemistry Products Calibrator Kit 7
For in vitro diagnostic use only.
Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros
Chemistry Systems for the quantitative measurement of CRP. |
Continued on next page
2
510(k) Summary, Continued
The Vitros Chemistry Products CRP Slides (modified) 7. Comparison to and Vitros Chemistry Products Calibrator Kit 7 are substantially predicate equivalent to Vitros Chemistry Products CRP Slides (current) and Vitros device Chemistry Products Calibrator Kit 7 which were cleared by the FDA for in vitro diagnostic use with human serum and plasma. (K953197, cleared July 31, 1995)
Table 1 lists the characteristics of the tests performed using the Vitros Chemistry Products CRP Slides (modified) and Vitros Chemistry Products CRP Slides (current slide).
| Table 1 List of Assay Characteristics: Comparison to Predicate Device | ||
|---|---|---|
| Device Characteristic | New Device | Predicate Device |
| Device Characteristic | New Device | |
| Vitros CRP Slide | ||
| (Modified) | Predicate Device | |
| Vitros CRP Slide | ||
| (Current) | ||
| Sample Volume | No Change. | 11 µL |
| Wash volume | No change | 12 µL |
| Intended Use | No Change. | For in vitro diagnostic use only. |
| Vitros CRP Slides quantitatively | ||
| measure C-reactive protein (CRP) | ||
| concentration in serum and plasma. | ||
| Basic Principle | No Change. | Dry multi-layered slide utilizing |
| reflectance spectrophotometry. | ||
| Sample Type | Serum | |
| Plasma (heparin and EDTA) | Serum | |
| Plasma (lithium heparin, | ||
| sodium citrate and EDTA) | ||
| Reportable Range Serum, Plasma | 0.3 - 11.0 mg/dL (Conv. Units) | |
| 3 - 110 mg/L (SI Units) | ||
| 300 - 11000 ug/dL (Alt. Units) | 0.7 - 110.0 mg/dL (Conv. Units) | |
| 7 - 110 mg/L (SI Units) | ||
| 700 - 11000 ug/dL (Alt. Units) | ||
| Instrumentation | No Change. | Vitros 250 and 950 Chemistry Systems |
| Incubation time and temperature | No Change. | 7.5 minutes at 37°C |
| Slide Reactive Ingredients per cm2: | ||
| Immobilized phosphorylcholine | No change | 0.07 mg |
| Anti-CRP antibody labeled with HRP | 0.0006 units | 0.0009 units |
| Calcium chloride | 0.08 mg | 0.10 mg |
| Leuco dye | No change | 0.04 mg |
Continued on next page
Vitros Chemistry Products CRP Slides Vitros Chemistry Products Calibrator Kit 7
3
510(k) Summary, Continued
The information presented in the pre-market notification demonstrate 8. Conclusion that the performance of the Vitros Chemistry Products CRP Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured CRP values spanning the reportable range.
The information presented in the premarket notification provide a reasonable assurance that the Vitros Chemistry Products CRP Slides (modified) is safe and effective for the stated intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the profiles, creating a sense of unity and human connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.
MAR 1 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Darlene J. Phillips Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
K030626 Trade/Device Name: VITROS Chemistry Products CRP Slide and VITROS Chemistry Products Calibrator Kit 7 Regulation Number: 21 CFR § 866.5270 Regulation Name: C-reactive protein immunological test systems Regulatory Class: II Product Code: DCK, JIT Dated: February 25, 2003 Received: February 27, 2003
Dear Ms. Phillips:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
5
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Statement of Intended Use
Page 1 of 1
| 510(k) Number (if known): | K030626 |
|---|---|
| Device Name: | Vitros Chemistry Products CRP Slides |
| Vitros Chemistry Products Calibrator Kit 7 | |
| Intended Use: | Vitros Chemistry Products CRP Slides |
| For in vitro diagnostic use only. | |
| Vitros Chemistry Products CRP Slides quantitatively measure | |
| C-reactive protein (CRP) concentration in serum and plasma. | |
| Vitros Chemistry Products Calibrator Kit 7 | |
| For in vitro diagnostic use only. | |
| Vitros Calibrator Kit 7 is intended for use in the calibration of | |
| the Vitros Chemistry Systems for the quantitative measurement | |
| of CRP. | |
| Summary and | |
| Explanation of Test | C-reactive protein is synthesized by the liver and is one of the |
| acute phase proteins. In the acute phase response, increased | |
| concentrations of a number of plasma proteins, including CRP, | |
| are observed. 1 | |
| CRP concentration measurements are useful in the detection and | |
| evaluation of inflammatory disorders, tissue injury, and | |
| infections. 2, 3 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Reeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030626
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1-2-96)
Vitros Chemistry Products CRP Slides Vitros Chemistry Products Calibrator Kit 7